The purpose of this study is to evaluate the efficacy and safety of CABENUVA (Long-acting Cabotegravir Plus Long-acting Rilpivirine) in patients with HIV infection and severe renal impairment. This study is considered research and is voluntary.
The purpose of this study is to evaluate CABENUVA (Long-acting Cabotegravir (CAB) Plus Long-acting Rilpivirine (RPV)) pharmacokinetics (movement of drugs within the body), safety and control of HIV in participants with renal (kidney) disease compared to historical values observed in those with normal renal function. Giving these drugs as an injection in your muscle (intramuscular) may offer be better tolerated by the body and may be simpler than taking a regular oral medication. Researchers want to find out if two drugs long-acting CABENUVA can help people with HIV and kidney disease when given every 8 weeks (2 months) or every 4 weeks (monthly). 12 patients will be enrolled into this study between two study sites. For the purposes of this project, we have applied for and received an FDA IND exemption (IND #161158) as this is a pilot study and not intended to result in a change in product labeling.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
At Day 1 all participants will initiate oral CAB 30 mg + RPV 25 mg once daily for at least 28 days during the Oral Phase. Participants will receive CAB LA 600 mg + RPV LA 900 mg IM injections at month 1 visit followed by CAB LA 400 mg + RPV LA 600 mg IM injections monthly at M2, M3, M4 and M5 visits. Then, starting at month 6 visit, participants will receive CAB LA 600 mg + RPV LA 900 mg IM injections every 2 months at M6, M8, M10 and M12.
Allegheny Health Network
Pittsburgh, Pennsylvania, United States
Cabotegravir plasma concentration over time
Since this is primarily a pharmacokinetics study, this descriptive outcome will demonstrate plasma concentration measures (Ctrough) versus time profiles for CAB LA.
Time frame: Month 2 through Month 12 (for Ctrough)
Cabotegravir plasma concentration over time
Since this is primarily a pharmacokinetics study, this descriptive outcome will demonstrate plasma concentration measures (Cmax) versus time profiles for CAB LA.
Time frame: Month 2 through Month 12 (for Cmax)
Cabotegravir area under the curve
Since this is primarily a pharmacokinetics study, this descriptive outcome will demonstrate "Area Under the Curve (AUC)" calculations for CAB LA.
Time frame: Month 1through Month 2, Month 5 through Month 6, and Month 10 through Month 12 (for AUC)
Rilpivirine plasma concentration over time
Since this is primarily a pharmacokinetics study, this descriptive outcome will demonstrate plasma concentration measures (Ctrough) versus time profiles for RPV LA.
Time frame: Month 2 through Month 12 (for Ctrough)
Rilpivirine plasma concentration over time
Since this is primarily a pharmacokinetics study, this descriptive outcome will demonstrate plasma concentration measures (Cmax) versus time profiles for RPV LA.
Time frame: Month 2 through Month 12 (for Cmax)
Rilpivirine area under the curve
Since this is primarily a pharmacokinetics study, this descriptive outcome will demonstrate "Area Under the Curve (AUC)" calculations for RPV LA.
Time frame: Month 1through Month 2, Month 5 through Month 6, and Month 10 through Month 12 (for AUC)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cabotegravir plasma concentration comparison between patients with severe renal impairment and those without severe renal impairment
Analysis of CAB LA plasma concentration measures (Ctrough) from participants with severe renal impairment compared to those from historical participants without severe renal impairment.
Time frame: Month 2 through Month 12
Cabotegravir plasma concentration comparison between patients with severe renal impairment and those without severe renal impairment
Analysis of CAB LA plasma concentration measures (Cmax) from participants with severe renal impairment compared to those from historical participants without severe renal impairment.
Time frame: Month 2 through Month 12
Cabotegravir plasma concentration comparison between patients with severe renal impairment and those without severe renal impairment
Analysis of CAB LA plasma concentration measures (AUC) from participants with severe renal impairment compared to those from historical participants without severe renal impairment.
Time frame: Month 2 through Month 12
Rilpivirine plasma concentration comparison between patients with severe renal impairment and those without severe renal impairment
Analysis of RPV LA plasma concentration measures (Ctrough) from participants with severe renal impairment compared to those from historical participants without severe renal impairment.
Time frame: Month 2 through Month 12
Rilpivirine plasma concentration comparison between patients with severe renal impairment and those without severe renal impairment
Analysis of RPV LA plasma concentration measures (Cmax) from participants with severe renal impairment compared to those from historical participants without severe renal impairment.
Time frame: Month 2 through Month 12
Rilpivirine plasma concentration comparison between patients with severe renal impairment and those without severe renal impairment
Analysis of RPV LA plasma concentration measures (AUC) from participants with severe renal impairment compared to those from historical participants without severe renal impairment.
Time frame: Month 2 through Month 12